Cleared Special

U2 ACETABULAR CUP, PLASMA SPRAY (K121777) - FDA 510(k) Clearance

Class II Orthopedic device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K121777 · United Orthopedic Corp. · Orthopedic device
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Jul 2012
Decision
30d
Days
Class 2
Risk

K121777 is an FDA 510(k) clearance for the U2 ACETABULAR CUP, PLASMA SPRAY. Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented (product code LPH), Class II - Special Controls.

Submitted by United Orthopedic Corp. (Hsinchu, TW). The FDA issued a Cleared decision on July 18, 2012 after a review of 30 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3358 - the FDA orthopedic device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all United Orthopedic Corp. devices

Submission Details

510(k) Number K121777 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 18, 2012
Decision Date July 18, 2012
Days to Decision 30 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
92d faster than avg
Panel avg: 122d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code LPH Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3358
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Orthopedic devices follow this clearance model.

Regulatory Peers - LPH Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented

All 325
Devices cleared under the same product code (LPH) and FDA review panel - the closest regulatory comparables to K121777.
ZMR HIP SYSTEM KWZ-PROSTHESIS, HIP, CONSTRAINED, CEMENTED OR UNCEMENTED, METAL/POLYMER
K113296 · Zimmer, Inc. · Sep 2012
POLARCUP DUAL MOBILITY SYSTEM
K122244 · Smith & Nephew, Inc. · Aug 2012
HIP SYSTEMS
K121308 · Howmedica Osteonics Corp. · Jul 2012
NOVATION INTEGRIP ACETABULAR AUGMENTS, GROUPS 4 AND 5
K113609 · Exactech, Inc. · Jan 2012
POLARCUP DUAL MOBILITY SYSTEM
K110135 · Smith & Nephew, Inc. · Oct 2011
CONTINUUM AND TRILOGY INTEGRATED TAPER (IT) ACETABULAR SYSTEMS
K103662 · Zimmer, Inc. · Apr 2011